Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery
ConditionUrinary Retention
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age55+
SponsorHackensack Meridian Health
About this trial
This is a feasibility study looking at whether the use of Tamsulosin could lower the high incidence of postoperative urinary retention (POUR) in older men who undergo an oncological thoracic surgical procedure for suspected or confirmed cancer. In addition, the study will try to identify the time of resumption of presurgical urinary function post Tamsulosin administration.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males
≥55 years old
Planned thoracic oncological surgical procedure of a video assisted oncological surgical procedure for suspected or confirmed cancer.
Surgery scheduled more than 7 days from the time of consent
Disqualifiers
Using Tamsulosin already
Known allergy to Tamsulosin or sulfa drugs
Current use of Boceprevir
Resting systolic blood pressure <100
Trial design
Design model
Single group
Treatments tested in this trial
Tamsulosin
DrugTamsulosin 0.4 mg one time daily after a meal for seven days prior to surgery. Post-surgery, an ultrasound of the bladder will be completed approximately six hours after surgery to assess the bladder. If the bladder ultrasound shows more than 400 cc of urine in the bladder, or if the study subject passes urine on his own and there is more than 100cc or less than 400 cc of urine left in the bladder, he will be encouraged to try to pass urine. Study subject will be monitored for two additional hours. If a study subject is unable to pass urine at this time or the bladder has 400 cc or more of urine left in it, he will have an intermittent catheter (in and out) to drain urine. If the bladder has greater than 500 cc (which is approximately 16 and two-thirds ounces) per catheterization for more than 24 hours, and the study subject cannot pass urine, an indwelling catheter may be considered.
Treatment groups
46 Participants
are divided into 1 treatment groupGroup A: Pre-operative Tamsulosin administrationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants that were able to spontaneously void after surgery completion
Self-reported void within 6-8 hours post operative
Time frame
6-8 hours post operative2
Time of the void
Time (number of minutes) to first postoperative spontaneous urination post operation
Time frame
Within 24 hours post operative3
Volume of urine
Volume of urine during the first postoperative spontaneous urination post operation.
Time frame
Within 24 hours post operative4
Amount of residual urine
Patients will receive a bladder scan post their first postoperative spontaneous urination and the amount of residual urine will be measured.
Time frame
Within 24 hours post operativeSponsors and contacts
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Source ClinicalTrials.gov